Out-Of-Hospital Cardiac ArrestPRECEDENCENCT07421882
PRE-hospital Cooling to improvE carDiac arrEst Neurological outComEs (PRECEDENCE)
A study testing CarbonCool® Cooling Vest in people with Out-Of-Hospital Cardiac Arrest and Cardiopulmonary Resuscitation, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
The PRE-hospital Cooling to improvE carDiac arrEst Neurological outComEs (PRECEDENCE) study is a pilot feasibility trial evaluating the implementation of pre-hospital targeted temperature management (TTM) using a wearable surface cooling device (CarbonCool® vest) in adult out-of-hospital cardiac arrest (OHCA) patients… Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest, Cardiopulmonary Resuscitation, Death, Sudden, Cardiac
- What is being tested?
- CarbonCool® Cooling Vest
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Feb 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Out-of-hospital cardiac arrest (OHCA) of any rhythm attended by Singapore Civil Defence Force (SCDF) paramedics.
- Return of spontaneous circulation (ROSC) achieved in the pre-hospital setting.
- Age ≥16 years and ≤80 years.
- Patient remains comatose after ROSC, with Glasgow Coma Scale (GCS) ≤8.
Who cannot join
- Age >80 years.
- Traumatic cause of cardiac arrest.
- Tympanic temperature <34°C at time of assessment.
- Pregnant females.
- Termination of resuscitation in the Emergency Department.
- Withdrawal of life support within 24 hours of Coronary Care Unit (CCU) admission.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
National University Heart Centre, Singapore (NUHCS)
Singapore, 119074
Kai Lee Woo, +6584136810, kai_lee_woo@nuhs.edu.sg
Shir Lynn Lim, MBBS
About this study
Official title: PRE-hospital Cooling to improvE carDiac arrEst Neurological outComEs (PRECEDENCE): a Pilot Feasibility Study
The PRE-hospital Cooling to improvE carDiac arrEst Neurological outComEs (PRECEDENCE) study is a pilot feasibility trial evaluating the implementation of pre-hospital targeted temperature management (TTM) using a wearable surface cooling device (CarbonCool® vest) in adult out-of-hospital cardiac arrest (OHCA) patients with return of spontaneous circulation (ROSC). The study aims to assess feasibility, fidelity, acceptability, and safety of initiating cooling in the field by emergency medical services (EMS) prior to hospital arrival. Results will inform the design of a larger definitive trial to determine the clinical effectiveness of early pre-hospital TTM in improving neurological outcomes.
Read the detailed description
Background: Despite advances in resuscitation, neurological recovery after out-of-hospital cardiac arrest (OHCA) remains poor. Current hospital-initiated targeted temperature management (TTM) often begins several hours after ROSC, potentially missing the optimal neuroprotective window. Early or ultra-early cooling during the pre-hospital phase may mitigate ischemia-reperfusion brain injury, but evidence from real-world EMS settings is limited.
Rationale: The PRECEDENCE study tests the operational feasibility of initiating TTM in the pre-hospital environment using a novel, power-free CarbonCool® cooling vest designed for rapid application by paramedics immediately after ROSC. The vest provides conductive surface cooling without interfering with resuscitation, transport, or diagnostics.
Study Design: PRECEDENCE is a pilot feasibility trial conducted by the Singapore Civil Defence Force (SCDF) and collaborating hospital. Eligible OHCA patients attended by SCDF Division 4 paramedics will be allocated to either (a) pre-hospital TTM using the CarbonCool® vest or (b) standard pre-hospital care, depending on predefined eligibility and operational criteria. Both groups will be prospectively followed through hospital discharge.
Outcomes: The primary outcome is feasibility of implementing pre-hospital TTM, evaluated through recruitment rates, intervention delivery, protocol fidelity, and provider acceptability. Secondary outcomes include hospital TTM uptake, time from ROSC to target temperature, neurological outcome at discharge (CPC 1-2), and predefined safety endpoints (overshoot cooling < 33 °C, hemodynamically significant bradyarrhythmias, and skin injury).
Significance: By assessing real-world feasibility and safety of early pre-hospital cooling, this pilot will provide critical implementation data and guide protocol refinements for a future multi-division or national randomized trial.
- Conditions
- Out-Of-Hospital Cardiac Arrest, Cardiopulmonary Resuscitation, Death, Sudden, Cardiac, Therapeutic Hypothermia
- Being tested
- CarbonCool® Cooling Vest
- Keywords
- Return of Spontaneous Circulation
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbonCool® Cooling VestDevice
The CarbonCool® vest is a power-free, thermoplastic polyurethane (TPU) surface cooling device containing a proprietary carbon-based cooling medium capable of high heat exchange (35 W/mK). It is designed for rapid pre-hospital application and continuous cooling during patient transport.
| Study group | Role | What they receive |
|---|---|---|
| Pre-hospital Targeted Temperature Management | Experimental | Eligible out-of-hospital cardiac arrest (OHCA) patients who achieve return of spontaneous circulation (ROSC) and meet inclusion criteria will receive early targeted temperature management (TTM) initiated in the pre-hospital setting by Singapore Civil Defence Force (SCDF) paramedics. Cooling is delivered using the CarbonCool® surface cooling vest, applied immediately after ROSC and maintained during transport to the receiving hospital. Upon hospital arrival, a 1-for-1 vest exchange is performed in the Emergency Department before continuation of standard post-cardiac arrest care. Receives: Device: CarbonCool® Cooling Vest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment feasibility
Proportion of EMS-attended, eligible OHCA patients who received pre-hospital TTM
Measured: Through study completion, anticipated to be one year
Intervention feasibility
Proportion of recruited OHCA patients receiving the TTM protocol as intended
Measured: Through study completion, anticipated to be one year
Proportion of cases with complete adherence of workflow and case report forms
Adherence of paramedics to workflow and case report forms
Measured: Through study completion, anticipated to be one year
Acceptability of Intervention Measure (AIM)
Paramedic acceptability of the intervention will be assessed using the validated Acceptability of Intervention Measure (AIM). The AIM consists of a 4-item questionnaire rated on a 5-point Likert scale, with higher scores indicating greater acceptability of the intervention. Range score between 4 to 20.
Measured: Time frame within 3 months of case recruitment
Intervention Appropriateness Measure (IAM)
Perceived appropriateness of the intervention will be evaluated using the validated Intervention Appropriateness Measure (IAM). The IAM is a 4-item questionnaire rated on a 5-point Likert scale, with higher scores indicating greater perceived fit and relevance of the intervention for prehospital care. Range score between 4 to 20.
Measured: Time frame within 3 months of case recruitment
Feasibility of Intervention Measure (FIM) scores
Feasibility of implementing the intervention in the operational prehospital setting will be assessed using the validated Feasibility of Intervention Measure (FIM). The FIM comprises 4 items rated on a 5-point Likert scale, with higher scores indicating greater perceived feasibility. Range score between 4 to 20.
Measured: Time frame within 3 months of case recruitment
Secondary outcomes (3)
Proportion of Eligible OHCA Patients Receiving Hospital TTM
Percentage of out-of-hospital cardiac arrest (OHCA) patients who meet inclusion criteria and subsequently receive targeted temperature management (TTM) in hospital.
Measured: 6 hours
Time to Achieve Target Core Temperature After ROSC
Duration (in minutes) from return of spontaneous circulation (ROSC) to achievement of target core temperature
Measured: 12 hours
Good Neurological Outcome at Hospital Discharge
Proportion of patients with a Cerebral Performance Category (CPC) score of 1 or 2 at hospital discharge.
Measured: To hospital discharge, with an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start1 Feb 2026
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Out-Of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study design to evaluate the feasibility of implementing pre-hospital targeted temperature management (TTM) using a wearable cooling vest compared with standard pre-hospital care. Eligible out-of-hospital cardiac arrest (OHCA) patients who achieve return of spontaneous circulation (ROSC) are assigned to the intervention (CarbonCool® vest) based on predefined clinical eligibility and operational criteria. They will be compared against historical controls as well as eligible patients (by inclusion/exclusion criteria) managed by EMS from Divisions 1 to 3. Both groups are prospectively observed for safety, and clinical outcomes.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore Civil Defence Force, National University Heart Centre, Singapore
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421882
- Sponsor's protocol ID
- PRECEDENCE 1.0
- Acronym
- PRECEDENCE
- Status last verified
- Jan 2026
- First submitted
- 1 Dec 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sasson C, Rogers MA, Dahl J, Kellermann AL. Predictors of survival from out-of-hospital cardiac arrest: a systematic review and meta-analysis. Circ Cardiovasc Qual Outcomes. 2010 Jan;3(1):63-81. doi: 10.1161/CIRCOUTCOMES.109.889576. Epub 2009 Nov 10.
PubMed 20123673Nielsen N, Wetterslev J, Cronberg T, Erlinge D, Gasche Y, Hassager C, Horn J, Hovdenes J, Kjaergaard J, Kuiper M, Pellis T, Stammet P, Wanscher M, Wise MP, Aneman A, Al-Subaie N, Boesgaard S, Bro-Jeppesen J, Brunetti I, Bugge JF, Hingston CD, Juffermans NP, Koopmans M, Kober L, Langorgen J, Lilja G, Moller JE, Rundgren M, Rylander C, Smid O, Werer C, Winkel P, Friberg H; TTM Trial Investigators. Targeted temperature management at 33 degrees C versus 36 degrees C after cardiac arrest. N Engl J Med. 2013 Dec 5;369(23):2197-206. doi: 10.1056/NEJMoa1310519. Epub 2013 Nov 17.
PubMed 24237006Dankiewicz J, Cronberg T, Lilja G, Jakobsen JC, Levin H, Ullen S, Rylander C, Wise MP, Oddo M, Cariou A, Belohlavek J, Hovdenes J, Saxena M, Kirkegaard H, Young PJ, Pelosi P, Storm C, Taccone FS, Joannidis M, Callaway C, Eastwood GM, Morgan MPG, Nordberg P, Erlinge D, Nichol AD, Chew MS, Hollenberg J, Thomas M, Bewley J, Sweet K, Grejs AM, Christensen S, Haenggi M, Levis A, Lundin A, During J, Schmidbauer S, Keeble TR, Karamasis GV, Schrag C, Faessler E, Smid O, Otahal M, Maggiorini M, Wendel Garcia PD, Jaubert P, Cole JM, Solar M, Borgquist O, Leithner C, Abed-Maillard S, Navarra L, Annborn M, Unden J, Brunetti I, Awad A, McGuigan P, Bjorkholt Olsen R, Cassina T, Vignon P, Langeland H, Lange T, Friberg H, Nielsen N; TTM2 Trial Investigators. Hypothermia versus Normothermia after Out-of-Hospital Cardiac Arrest. N Engl J Med. 2021 Jun 17;384(24):2283-2294. doi: 10.1056/NEJMoa2100591.
PubMed 34133859Herzog CA, Ma JZ, Collins AJ. Long-term outcome of renal transplant recipients in the United States after coronary revascularization procedures. Circulation. 2004 Jun 15;109(23):2866-71. doi: 10.1161/01.CIR.0000129317.12580.68. Epub 2004 May 24.
PubMed 15159290Anthanont P, Jensen MD. Does basal metabolic rate predict weight gain? Am J Clin Nutr. 2016 Oct;104(4):959-963. doi: 10.3945/ajcn.116.134965. Epub 2016 Aug 31.
PubMed 27581474Yap LG, Shahidah N, Pothiawala S, et al. Novel wearable cooling device for early initiation of targeted temperature management in the Emergency Department. J Emerg Crit Care Med. 2020;4:5598.
Sayad A, Omrani MD, Solgi G, Noroozi R, Arsang-Jang S, Inoko H, Taheri M. Interleukin 7 Receptor Alpha Gene Variants Are Correlated with Gene Expression in Patients with Relapsing-remitting Multiple Sclerosis. Iran J Allergy Asthma Immunol. 2017 Aug;16(4):338-346.
PubMed 28865414Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.
PubMed 27777223
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRE-hospital Cooling to improvE carDiac arrEst Neurological outComEs (PRECEDENCE): a Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT07421882
- Acronym / sponsor ID
- PRECEDENCE / PRECEDENCE 1.0
- Conditions
- Out-Of-Hospital Cardiac Arrest, Cardiopulmonary Resuscitation, Death, Sudden, Cardiac, Therapeutic Hypothermia
- Keywords
- Return of Spontaneous Circulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- Singapore Civil Defence Force, National University Heart Centre, Singapore
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The PRE-hospital Cooling to improvE carDiac arrEst Neurological outComEs (PRECEDENCE) study is a pilot feasibility trial evaluating the implementation of pre-hospital targeted temperature management (TTM) using a wearable surface cooling device (CarbonCool® vest) in adult out-of-hospital cardiac arrest (OHCA) patients with return of spontaneous circulation (ROSC). The study aims to assess feasibility, fidelity, acceptability, and safety of initiating cooling in the field by emergency medical services (EMS) prior to hospital arrival. Results will inform the design of a larger definitive trial to determine the clinical effectiveness of early pre-hospital TTM in improving neurological outcomes.
Detailed description
Background: Despite advances in resuscitation, neurological recovery after out-of-hospital cardiac arrest (OHCA) remains poor. Current hospital-initiated targeted temperature management (TTM) often begins several hours after ROSC, potentially missing the optimal neuroprotective window. Early or ultra-early cooling during the pre-hospital phase may mitigate ischemia-reperfusion brain injury, but evidence from real-world EMS settings is limited.
Rationale: The PRECEDENCE study tests the operational feasibility of initiating TTM in the pre-hospital environment using a novel, power-free CarbonCool® cooling vest designed for rapid application by paramedics immediately after ROSC. The vest provides conductive surface cooling without interfering with resuscitation, transport, or diagnostics.
Study Design: PRECEDENCE is a pilot feasibility trial conducted by the Singapore Civil Defence Force (SCDF) and collaborating hospital. Eligible OHCA patients attended by SCDF Division 4 paramedics will be allocated to either (a) pre-hospital TTM using the CarbonCool® vest or (b) standard pre-hospital care, depending on predefined eligibility and operational criteria. Both groups will be prospectively followed through hospital discharge.
Outcomes: The primary outcome is feasibility of implementing pre-hospital TTM, evaluated through recruitment rates, intervention delivery, protocol fidelity, and provider acceptability. Secondary outcomes include hospital TTM uptake, time from ROSC to target temperature, neurological outcome at discharge (CPC 1-2), and predefined safety endpoints (overshoot cooling < 33 °C, hemodynamically significant bradyarrhythmias, and skin injury).
Significance: By assessing real-world feasibility and safety of early pre-hospital cooling, this pilot will provide critical implementation data and guide protocol refinements for a future multi-division or national randomized trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study design to evaluate the feasibility of implementing pre-hospital targeted temperature management (TTM) using a wearable cooling vest compared with standard pre-hospital care. Eligible out-of-hospital cardiac arrest (OHCA) patients who achieve return of spontaneous circulation (ROSC) are assigned to the intervention (CarbonCool® vest) based on predefined clinical eligibility and operational criteria. They will be compared against historical controls as well as eligible patients (by inclusion/exclusion criteria) managed by EMS from Divisions 1 to 3. Both groups are prospectively observed for safety, and clinical outcomes.
| Arm | Type | Receives |
|---|---|---|
| Pre-hospital Targeted Temperature Management | Experimental | Device: CarbonCool® Cooling VestEligible out-of-hospital cardiac arrest (OHCA) patients who achieve return of spontaneous circulation (ROSC) and meet inclusion criteria will receive early targeted temperature management (TTM) initiated in the pre-hospital setting by Singapore Civil Defence Force (SCDF) paramedics. Cooling is delivered using the CarbonCool® surface cooling vest, applied immediately after ROSC and maintained during transport to the receiving hospital. Upon hospital arrival, a 1-for-1 vest exchange is performed in the Emergency Department before continuation of standard post-cardiac arrest care. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Out-of-hospital cardiac arrest (OHCA) of any rhythm attended by Singapore Civil Defence Force (SCDF) paramedics.
- Return of spontaneous circulation (ROSC) achieved in the pre-hospital setting.
- Age ≥16 years and ≤80 years.
- Patient remains comatose after ROSC, with Glasgow Coma Scale (GCS) ≤8.
Key exclusion criteria (6 listed)
- Age >80 years.
- Traumatic cause of cardiac arrest.
- Tympanic temperature <34°C at time of assessment.
- Pregnant females.
- Termination of resuscitation in the Emergency Department.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarbonCool® Cooling VestThe CarbonCool® vest is a power-free, thermoplastic polyurethane (TPU) surface cooling device containing a proprietary carbon-based cooling medium capable of high heat exchange (35 W/mK). It is designed for rapid pre-hospital application and continuous cooling during patient transport. | Device | Pre-hospital Targeted Temperature Management |
Primary outcome
Recruitment feasibility
Time frame: Through study completion, anticipated to be one year
Proportion of EMS-attended, eligible OHCA patients who received pre-hospital TTM
Intervention feasibility
Time frame: Through study completion, anticipated to be one year
Proportion of recruited OHCA patients receiving the TTM protocol as intended
Proportion of cases with complete adherence of workflow and case report forms
Time frame: Through study completion, anticipated to be one year
Adherence of paramedics to workflow and case report forms
Acceptability of Intervention Measure (AIM)
Time frame: Time frame within 3 months of case recruitment
Paramedic acceptability of the intervention will be assessed using the validated Acceptability of Intervention Measure (AIM). The AIM consists of a 4-item questionnaire rated on a 5-point Likert scale, with higher scores indicating greater acceptability of the intervention. Range score between 4 to 20.
Intervention Appropriateness Measure (IAM)
Time frame: Time frame within 3 months of case recruitment
Perceived appropriateness of the intervention will be evaluated using the validated Intervention Appropriateness Measure (IAM). The IAM is a 4-item questionnaire rated on a 5-point Likert scale, with higher scores indicating greater perceived fit and relevance of the intervention for prehospital care. Range score between 4 to 20.
Feasibility of Intervention Measure (FIM) scores
Time frame: Time frame within 3 months of case recruitment
Feasibility of implementing the intervention in the operational prehospital setting will be assessed using the validated Feasibility of Intervention Measure (FIM). The FIM comprises 4 items rated on a 5-point Likert scale, with higher scores indicating greater perceived feasibility. Range score between 4 to 20.
3 secondary outcomes
Proportion of Eligible OHCA Patients Receiving Hospital TTM
Time frame: 6 hours
Time to Achieve Target Core Temperature After ROSC
Time frame: 12 hours
Good Neurological Outcome at Hospital Discharge
Time frame: To hospital discharge, with an average of 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 20123673Sasson C, Rogers MA, Dahl J, Kellermann AL. Predictors of survival from out-of-hospital cardiac arrest: a systematic review and meta-analysis. Circ Cardiovasc Qual Outcomes. 2010 Jan;3(1):63-81. doi: 10.1161/CIRCOUTCOMES.109.889576. Epub 2009 Nov 10.
- Background: PubMed 24237006Nielsen N, Wetterslev J, Cronberg T, Erlinge D, Gasche Y, Hassager C, Horn J, Hovdenes J, Kjaergaard J, Kuiper M, Pellis T, Stammet P, Wanscher M, Wise MP, Aneman A, Al-Subaie N, Boesgaard S, Bro-Jeppesen J, Brunetti I, Bugge JF, Hingston CD, Juffermans NP, Koopmans M, Kober L, Langorgen J, Lilja G, Moller JE, Rundgren M, Rylander C, Smid O, Werer C, Winkel P, Friberg H; TTM Trial Investigators. Targeted temperature management at 33 degrees C versus 36 degrees C after cardiac arrest. N Engl J Med. 2013 Dec 5;369(23):2197-206. doi: 10.1056/NEJMoa1310519. Epub 2013 Nov 17.
- Background: PubMed 34133859Dankiewicz J, Cronberg T, Lilja G, Jakobsen JC, Levin H, Ullen S, Rylander C, Wise MP, Oddo M, Cariou A, Belohlavek J, Hovdenes J, Saxena M, Kirkegaard H, Young PJ, Pelosi P, Storm C, Taccone FS, Joannidis M, Callaway C, Eastwood GM, Morgan MPG, Nordberg P, Erlinge D, Nichol AD, Chew MS, Hollenberg J, Thomas M, Bewley J, Sweet K, Grejs AM, Christensen S, Haenggi M, Levis A, Lundin A, During J, Schmidbauer S, Keeble TR, Karamasis GV, Schrag C, Faessler E, Smid O, Otahal M, Maggiorini M, Wendel Garcia PD, Jaubert P, Cole JM, Solar M, Borgquist O, Leithner C, Abed-Maillard S, Navarra L, Annborn M, Unden J, Brunetti I, Awad A, McGuigan P, Bjorkholt Olsen R, Cassina T, Vignon P, Langeland H, Lange T, Friberg H, Nielsen N; TTM2 Trial Investigators. Hypothermia versus Normothermia after Out-of-Hospital Cardiac Arrest. N Engl J Med. 2021 Jun 17;384(24):2283-2294. doi: 10.1056/NEJMoa2100591.
- Background: PubMed 15159290Herzog CA, Ma JZ, Collins AJ. Long-term outcome of renal transplant recipients in the United States after coronary revascularization procedures. Circulation. 2004 Jun 15;109(23):2866-71. doi: 10.1161/01.CIR.0000129317.12580.68. Epub 2004 May 24.
- Background: PubMed 27581474Anthanont P, Jensen MD. Does basal metabolic rate predict weight gain? Am J Clin Nutr. 2016 Oct;104(4):959-963. doi: 10.3945/ajcn.116.134965. Epub 2016 Aug 31.
- BackgroundYap LG, Shahidah N, Pothiawala S, et al. Novel wearable cooling device for early initiation of targeted temperature management in the Emergency Department. J Emerg Crit Care Med. 2020;4:5598.
- Background: PubMed 28865414Sayad A, Omrani MD, Solgi G, Noroozi R, Arsang-Jang S, Inoko H, Taheri M. Interleukin 7 Receptor Alpha Gene Variants Are Correlated with Gene Expression in Patients with Relapsing-remitting Multiple Sclerosis. Iran J Allergy Asthma Immunol. 2017 Aug;16(4):338-346.
- Background: PubMed 27777223Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CarbonCool® Cooling Vest in people with Out-Of-Hospital Cardiac Arrest and Cardiopulmonary Resuscitation, run by Singapore General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shir Lynn Lim, MBBS (+65 91760383, shir.lynn.lim@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment feasibility (time frame: Through study completion, anticipated to be one year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07421882, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.